Market News & Trends
Minerva Neurosciences Announces Update on its NDA for the Treatment of Negative Symptoms in Schizophrenia
Minerva Neurosciences, Inc. recently announced that following the Type A meeting held on November 30, 2022, the US FDA has confirmed the refuse to file…
Eyenovia Aims to Revolutionize Ophthalmology Devices With Microdose Array Print (MAP) Technology
While medical devices have seen incredible advancements over the last 100 years, ocular drug delivery systems have seen minimal progress; the standard eye dropper used today has gone largely unchanged….
Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Valneva SE recently announced it has completed rolling submission of the Biologics License Application (BLA) to the US FDA for its single-shot chikungunya vaccine candidate, VLA1553.…
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV Technologies recently announced that the US FDA has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety,…
KemPharm Announces Initiation of Phase 2 Clinical Trial Investigating KP1077 for the Treatment of Idiopathic Hypersomnia
KemPharm, Inc. recently announced the initiation of a Phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep…
Jazz Pharmaceuticals & Zymeworks Announce Jazz has Confirmed Opt-In & Advances Partnership
Jazz Pharmaceuticals plc and Zymeworks Inc. recently announced Jazz has exercised its option to continue with its exclusive development and commercialization rights to Zymeworks’ zanidatamab in key markets….
Achieve Life Sciences Announces Patent Granted by USPTO for New Cytisinicline Formulation
Achieve Life Sciences, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,459,328 covering the mesylate salt formulation…
atai Life Sciences Initiates Phase 2b Proof-of-Concept Trial of RL-007 for Cognitive Impairment Associated With Schizophrenia
The Phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS)…..
Carrick Therapeutics & The Menarini Group Announce Clinical Trial Collaboration
Carrick Therapeutics and the Menarini Group recently announced a clinical trial collaboration and supply agreement that covers the execution of a Phase 2 clinical trial to evaluate the novel combination of….
BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients With Alzheimer’s Disease
BioXcel Therapeutics, Inc. recently announced the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the…
Paratek Pharmaceuticals Announces Positive Top Line Data From Pilot Efficacy Study for the Treatment of Pulmonary Anthrax & Acceptance of the Second Procurement of NUZYRA Under BARDA Project BioShield
Paratek Pharmaceuticals, Inc. recently announced positive top line data from a pilot rabbit efficacy study evaluating NUZYRA’s effectiveness in the treatment of pulmonary anthrax. In the study, a 100% survival rate….
Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates
Assembly Biosciences, Inc. recently announced promising interim efficacy, safety and pharmacokinetic (PK) results from two ongoing clinical studies of its investigational next-generation HBV core inhibitors,…
F2G Announces FDA Filing Acceptance of NDA for Olorofim for the Treatment of Invasive Fungal Infections
F2G Inc. recently announced the US FDA has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections…
Adagene Announces Clinical Trial Collaboration to Evaluate Anti-CTLA-4 SAFEbody ADG126 in Combination With Roche’s Standard-of-Care for First-Line Advanced Liver Cancer
Adagene Inc. recently announced a clinical trial collaboration with Roche to evaluate the triple combination of Adagene’s ADG126 with Roche’s atezolizumab and bevacizumab in first-line treatment of….
Ocugen Announces Phase 3 Confirmatory Clinical Trial Agreement for NeoCart
Ocugen, Inc. recently announced the US FDA agreed to Ocugen’s proposed control and overall design for the Phase 3 study of NeoCart, a regenerative cell…
Tarsus Announces Positive Topline Data from Phase 1b Callisto Trial & Initiates Phase 2a Carpo Human Tick Kill Trial Evaluating TP-05, a Novel, Oral Therapeutic for the Prevention of Lyme Disease
Tarsus Pharmaceuticals, Inc. recently announced positive topline results from the completed Phase 1b Callisto trial and the enrollment of the first subject in the Carpo Phase 2a trial…..
Synlogic Announces Achievement of Proof of Concept for SYNB8802 in Enteric Hyperoxaluria Based on Urinary Oxalate Lowering in Phase 1b Study
Synlogic, Inc. recently announced that SYNB8802 has demonstrated proof of concept through clinically significant lowering of urinary oxalate in a Phase 1b study in patients…
Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina
Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research Triangle, to offer comprehensive stand-alone…
MoonLake Immunotherapeutics Screens First Patient in Phase 2 Study of the Nanobody Sonelokimab in Active Psoriatic Arthritis
MoonLake Immunotherapeutics AG recently announced the first subject has been screened in the US in a Phase 2 clinical study of the Nanobody sonelokimab in patients with….
Urica Therapeutics Expands Exclusive License Agreement With Fuji Yakuhin Co. Ltd.
Urica Therapeutics, Inc. recently announced it has expanded its exclusive license agreement with Fuji Yakuhin Co. Ltd. for the development of dotinurad to include the…
